HT31-1 for ARDS

Overseen By Lacey Harris, MPH, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: HTIC, Inc

Must not be taking: Immunosuppressants, Biologics, others

Disqualifiers: Autoimmune disease, Hepatitis, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source.

The current trial (Part A) focuses on single ascending doses (SAD) in healthy volunteers to characterize the safety profile, PK parameters, and immunogenicity of HT31-1. Emerging data from this phase will inform dose selection for the subsequent Part B study in ARDS patients and help establish the recommended Phase 2 dose (RP2D). Additionally, exploratory pharmacodynamic and biomarker assessments will be performed to evaluate target engagement and potential early biological activity.

Who Is on the Research Team?

Jianjie Ma, PhD

Principal Investigator

HTIC, Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

Body Mass Index (BMI) between 18.0 and 32.0 kg/m², inclusive

Screening clinical laboratory tests within normal ranges or not clinically significant

I agree to use two effective birth control methods with my partner.

Exclusion Criteria

History of tetanus infection or recent tetanus toxoid vaccine receipt

Difficulty with venous access or an inability to tolerate blood draws

Positive screening alcohol breath test or history of excessive alcohol intake

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single ascending dose (SAD) administration of HT31-1 to evaluate safety, tolerability, and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and pharmacokinetic parameters

28 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• HT31-1

How Is the Trial Designed?

Group I: Cohort 3: 20 mg/kg Experimental Treatment 1 Intervention

HT31-1 20mg/kg single intravenous dosing

Group II: Cohort 2: 5 mg/kg Experimental Treatment 1 Intervention

HT31-1 5mg/kg single intravenous dosing

Group III: Cohort 1: 1 mg/kg Experimental Treatment 1 Intervention

HT31-1 1mg/kg single intravenous dosing

Group IV: Cohort 1: Placebo Placebo Group 1 Intervention

Saline single intravenous dosing

Group V: Cohort 2: Placebo Placebo Group 1 Intervention

Saline single intravenous dosing

Group VI: Cohort 3: Placebo Placebo Group 1 Intervention

Saline single intravenous dosing

Who Is Running the Clinical Trial?

HTIC, Inc

Lead Sponsor